Cleared Traditional

K980982 - AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2

K980982 is an FDA 510(k) clearance for AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AN..., manufactured by Avocet Medical, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K980982 · Avocet Medical, Inc. · Hematology device
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Apr 1998
Decision
30d
Days
Class 2
Risk

K980982 is an FDA 510(k) clearance for the AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Avocet Medical, Inc. (Campbell, US). The FDA issued a Cleared decision on April 16, 1998 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avocet Medical, Inc. devices

FDA 510(k) Submission Details - K980982

510(k) Number K980982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1998
Decision Date April 16, 1998
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 113d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GGN Plasma, Coagulation Control

All 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K980982.
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K964716 · American Bioproducts Co. · Jun 1997